- EU approves Dupixent for COPD patients unresponsive to standard treatments.
- FDA delays Dupixent review until September for additional data.
- Dupixent sales expected to rise significantly with expanded use.
Sanofi and Regeneron have gained European Union approval for the use of their Dupixent injection to treat chronic obstructive pulmonary disease (COPD), an ailment commonly referred to as “smoker’s lungs.
In contrast, the U.S. Food and Drug Administration (FDA) has postponed its review of Dupixent for COPD until September 27, 2024, to collect more efficacy data. COPD, which leads to restricted airflow and significant breathing difficulties, affects around 16 million adults in the U.S. and over 35 million in Europe.
Sanofi’s Dupixent Receives EU Approval for Broader COPD Treatment
Sanofi, in partnership with Regeneron, has received approval from the European Union for the use of their Dupixent injection in treating chronic obstructive pulmonary disease (COPD). This approval is significant as it represents one of the few times the EU has approved a drug faster than the United States. The European Commission’s decision follows a recommendation from the European Medicines Agency (EMA) at the end of May.
The approval targets COPD patients who do not respond to standard inhaled treatments, providing a new treatment option for this debilitating condition. Commonly known as “smoker’s lungs,” COPD primarily affects cigarette smokers in Western countries and leads to severe respiratory issues. The EU’s decision could potentially improve the quality of life for millions of patients suffering from this chronic disease.
Meanwhile, the U.S. Food and Drug Administration (FDA) has extended its review period for Dupixent in COPD until September 27, 2024. The delay is intended to allow the collection of additional efficacy data to support the drug’s approval. Despite the delay, Sanofi remains optimistic about the drug’s potential, estimating that around 300,000 patients in the U.S. could benefit from Dupixent once approved.
Dupixent is already approved in multiple countries for various conditions related to the immune system, such as asthma and eczema. In 2023, Sanofi reported revenues of 10.7 billion euros from Dupixent, including Regeneron’s share, and is projecting revenues of around 13 billion euros for 2024. The expanded use of Dupixent for COPD is expected to significantly boost these figures.
With the EU’s approval and the FDA’s pending review, Dupixent is poised to become a key treatment option for COPD patients globally, potentially improving the lives of millions suffering from this chronic condition.
“Sanofi said in April it expects the target patient population eligible for the drug to be roughly 300,000 patients in the US alone.”
